MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

The exact age of the patient is unknown, however, it was reported the patient was over 18 years.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during a vaginal prolapse with uphold mesh procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the suture near the dilator broke when the physician tried to pull the device through the patient's right ligament.Reportedly, the suture was left free hanging during deployment.In addition, the patient has reportedly a strong ligament.The procedure was completed with another uphold lite with capio slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

The exact age of the patient is unknown, however, it was reported the patient was over 18 years.Problem code 2907 captures the reportable event of suture detachment.A capio slim suturing device, an uphold lite mesh assembly, and a detached portion of dilator and suture were received.A visual examination of the returned mesh assembly revealed that the dilator and suture were detached from the mesh assembly on the blue dilator.There was damage along the length of the blue dialator.No other damage was noted to the mesh assembly.The blue and white dilator, protective sleeves, leader loops and mesh were intact.The edge where the dilator had detached was jagged.The dilator was cut open, and it was found that there was no suture inside.A visual inspection of the returned detached portion revealed that there were several holes in the blue dilator, and the material appeared to be thin in places as if stretched.The non-dart side of the suture could be seen coming the detached area.The cut where the dilator was detached and was jagged.Furthermore, inspection of the returned capio slim device showed that there were some residues and signs of use on the head of the device.No other visual abnormalities were noted.Functional test of the capio slim device with the intact blue and white dilator showed no issues.The dart was loaded and the carrier arm extended and retracted from the capio cage.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the condition of returned device, it is probable that operational factors, such as the user handling/technique and patient anatomy, resulted in the user encountering difficulty during the procedure and subsequently damaging the blue dilator, stretching the dilator and ultimately detaching the dilator.Therefore, the complaint investigation conclusion code selected is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during a vaginal prolapse with uphold mesh procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the suture near the dilator broke when the physician tried to pull the device through the patient's right ligament.Reportedly, the suture was left free hanging during deployment.In addition, the patient has reportedly a strong ligament.The procedure was completed with another uphold lite with capio slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8471969
• MDR Text Key: 140591122
• Report Number: 3005099803-2019-01537
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0022759890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1